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Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
EC number: 943-062-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study". Federal Register, Vol. 43 No. 163 August 22, 1978
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
- EC Number:
- 943-062-2
- Molecular formula:
- not available
- IUPAC Name:
- Reaction mass of Cobaltate(1-), bis[6-(amino-κN)-5-[2-[2-(hydroxy-κO)-4-nitrophenyl]diazenyl-κN1]-N-methyl-2-naphthalenesulfonamidato(2-)]-, sodium (1:1) and disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Code No: FAT 20036/D
Batch No: EN 91018.22
Stability: May 1987
Description: Powder
Test Article Received: June 6, 1982
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Hadoerin AG, CH-4414 Fuellinsdorf.
- Weight at study initiation: between 2 to 3 kg.
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit foodr NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland).
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 4 days.
- Individual identification: ear numbers.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod: 12 hours light cycle day and approximately 15 air changes/h.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Right eye of each rabbit remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- One single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male and 3 female rabbits
- Details on study design:
- The test material (0.1 g) was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. In 3 of the 6 rabbits, approximately 30 seconds later, In after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.
The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment.
SCORING SYSTEM:
CORNEA
A. Opacity and degree of density (most dense area scored)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent aereas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter, but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4
A x B x 5
Maximum possible score 80
IRIS
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcornea injection (any or all of theses or combination of any thereof) iris still reaction to light (sluggish reaction is positive): 1
- No reaction to light, hemorrhage, gross destruction (any or all of these): 2
A x 5
Maximum possible score 10
CONJUNCTIVAE
A. Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis
- No swelling 0
- Any swelling above normal (includes nictating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4
C. Discharge
- No discharge: 0
- Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the l i d s and hairs, and considerable area around the eye: 3
(A + B + C) x 2
Maximum possible score : 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Rinsed and non rinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Rinsed and Unrinsed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Rinsed and unrinsed eye
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Rinsed and unrinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- FAT 20'036/D was found to cause miniaal irritation when applied to the rabbit eye mucosa.
- PRIMARY IRRITATION INDEX IN UNRINSED EYES: A= 6.7 : 5 = 1.3
- PRIMARY IRRITATION INDEX IN RINSED EYES: B= 4.0 : 5 = 0.8 - Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20'036/D was concluded to be not an eye irritant.
- Executive summary:
An acute eye irritation study was performed on New Zealand white rabbits to determine the irritant potency of FAT 20036/D. The procedure used is based, but not in
every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study". Federal Register, Vol. 43 No. 163 August 22, 1978. The test material (0.1 g) was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits, approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
No irritation reactions were noticed with cornea and iris. The scores obtained for conjunctival redness and chemosis were below the threshold scores for classification as established by Regulation (EC) No. 1272/2008. The calculated primary irritation index was: 1.3 in unrinsed eyes and 0.8 in rinsed eyes. Hence, it can be concluded that under the conditions of the present experiment FAT 20036/D is not an irritant to eyes.
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